DIPALI PADALKAR
EtMf Document Specialist
Mumbai
Summary
Organized and motivated clinical research professional ready to work. Highly motivated, reliable professional eager to apply my exceptional organizational skills to a clinical research role. Experienced in regulatory document management for pharmaceutical and medical device trials. Seeking a Clinical Research position and opportunities to expand skills while facilitating company growth.
Overview
4
4
years of professional experience
4
4
Certifications
Work History
Etmf Document Specialist
Tata Consultancy Services Pvt Ltd
11.2022 - Current
- supporting TMF document integration into modern eTMF system while adhering to naming and filing guidelines specific to TMF documents
- executing quality checks and document content review uploaded into etmf
- Facilitates effective communication with clinical trial team and CRO staff during trial start-up, maintenance, closeout, and archival phases.
- Managed expected document list (EDL) to monitor trial master file (TMF) health for assigned trials.
- Managed open quality issues failing TMF quality control standards. Streamlined resolution processes to enhance compliance with TMF guidelines. Conducted thorough investigations into quality failures to identify root causes. Collaborated with cross-functional teams to implement corrective actions effectively.
- responding to inquiries regarding trial master file management and content
- maintains current knowledge of tmf reference model industry standards and regulatory requirements
- facilitating inspection or audit readiness and remediation efforts
- Ensure finalization of study documentation for migration purposes and facilitate query resolution with relevant personnel
- expertise in applicable regulations and guidelines related to regulatory documents and familiarity with medical terminology.
- management of regulatory documents (e.g. FDA 1572, CVS, FDF, etc.)
- offering backup management support to manager document control and senior etmf analysts
- supporting manager, document control, and senior management as assigned, performing additional duties as required
- Conduct quality review of documents submitted for entry into TMF and collaborate with project teams to address identified issues.
- process study documentation according to standard operating procedures, work instructions, GCP, ICH guidelines, and study-specific criteria
- document collection activities facilitate setup, maintenance, and closure of tmf repositories
- ensures security and compliance of all documents related to active and archived projects
- Participated in meetings and training sessions to enhance professional knowledge.
Associate: Medical Reimbursement
Larsen and Turbo Ltd
11.2021 - 10.2022
- Producing scientific documentation from patient history and medical reports.
- Review of patient history, medical reports
- Review patient prescription
Education
Bachelor Of Pharmacy - undefined
C.U.Shah College of Pharmacy (Sndt University)
Mumbai06-2021
Secondary School - undefined
Science And Technology Swami Vivekananda Junior College
Mumbai06-2017
Skills
Electronic data capture (EDC), Metadata, e TMF, CTMS, TMF, FirstDoc
Software - BIRDS, Metadata, clinergize
Written and Verbal Communication skills
Organizational and Time Management skills
Regulatory Document Review
Clinical Trials/ Clinical Operations
Team/Matrix environment skills
GCP/ICH Guideline Competency
SOP Implementation
Analytical skills
Indexing
Organizational skills
Talent and Development Optimization
Prioritization
Project Management skills
Attention to Detail
Teamwork and Collaboration
ER MDR Remediation
Microsoft Office (Word, Excel, and PowerPoint, and MS Project)
Regulatory Compliance
Administrative coordination
Certification
Generative AI
Accomplishments
- Star Of the Month award at TCS (Apr-2024)
- Best CO-worker award received in Larsen and Turbo Ltd (Feb-2022)
Timeline
Etmf Document Specialist
Tata Consultancy Services Pvt Ltd
11.2022 - Current
Associate: Medical Reimbursement
Larsen and Turbo Ltd
11.2021 - 10.2022
Bachelor Of Pharmacy - undefined
C.U.Shah College of Pharmacy (Sndt University)
Secondary School - undefined
Science And Technology Swami Vivekananda Junior College